KSEA ENDO TIP SYSTEM

K981130 · KARL STORZ Endoscopy-America, Inc. · HET · Aug 19, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K981130
• Device Name: KSEA ENDO TIP SYSTEM
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Aug 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The KSEA EndoTIP System is intended for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures.

Device Story

The KSEA EndoTIP System is a manual, reusable surgical cannula designed for Ob/Gyn laparoscopic procedures. It consists of a threaded hollow cannula with a blunt penetrating distal end. The device is used by surgeons or physicians to provide access to the patient's body cavity, facilitating the insertion of endoscopes and endoscopic accessories. It is supplied non-sterile and requires sterilization by the end-user before use. The device is constructed from surgical-grade stainless steel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual, reusable surgical cannula. Materials: surgical grade stainless steel. Form factor: threaded hollow cannula with blunt penetrating distal end. Non-sterile delivery; requires user sterilization.

Indications for Use

Indicated for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS AUG 1 9 1998

K481130

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan<br>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Cannula |
| | Trade Name: (optional)<br>KSEA EndoTIP System |

Indication: The KSEA EndoTIP System is intended for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures.

Device Description: The KSEA EndoTIP System are manual reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA EndoTIP System is comprised of a threaded hollow cannula with a blunt penetrating distal end. The body contact materials are surgical grade stainless steel.

Substantial Equivalence: The KSEA EndoTIP System for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures are substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences in design and dimensions between the KSEA EndoTIP System and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.

Signed:

ed:

Kevin Kennan

Senior Regulatory Affairs Specialist

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Image /page/1/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN..." around the left side and "...USA" on the right side. Inside the circle is a symbol consisting of three curved shapes that resemble stylized waves or ribbons. The image is in black and white and appears to be a scan or photocopy, as there are some artifacts and imperfections in the image quality.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 1998

Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600

Re: K981130

EndoTIP™ System Dated: June 29, 1998 Received: June 30, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET

Dear Mr. Kennan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/odrh/dsmadsmamain.html".

Sincerely yours.

Lillian Yin. Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Not yet assigned

K981130

Device Name: EndoTIP System

Indications for Use: These instruments are intended for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic surgical and diagnostic procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981130

Prescription Use: OR Over-The-Counter Use: **__**
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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